systemic light-chain amyloidosis
Conditions
Interventions
Case series:None
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Patient=18 years old, diagnosed as systemic light-chain amyloidosis; 2.Patients who are using or will be treated with SDd regime; 3.At the beginning of this treatment plan, patient should: a. NEU#= 1.0×10^9/L b. Hb=8.0g/dL c. PLT#=75×10^9/L 4.Measurable disease of amyloid light-chain (AL) amyloidosis as defined by at least one of the following a. Serum monoclonal (M)-protein greater than or equal (>=) 0.5 grams/deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation [IFE] performed at a central laboratory); b. Serum free light chain greater than or equal to (>=) 50 milligram/Liter (mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) >= 50 mg/L; 5.The patients who are willing to provide personal and medical history information, and cooperate with clinical management; 6.Patients were informed the study and sign the ICF.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1.Non-AL amyloidosis; 2.Patients who hypersensitivity to Selinexor, anti-CD38 or excipients; 3.Patient has known malignant tumor except AL- amyloidosis within the past 3 years; 4.There is a combined medical condition or disease, such as significant cardiovascular condition(New York Heart Association (NYHA) classification IIIB or IV heart failure et al), known to be seropositive for human immunodeficiency virus (HIV), active hepatitis B/C, or active systemic infection that may interfere with the research process or results, or is determined by the investigators to pose a certain risk to participation in the study 5.Patients who are known or suspected to be unable to comply with the study program (for example, alcoholism, drug dependence or psychological disorders, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Overall Complete Hematologic Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Organ response;Time to organ response;Duration of organ response;Hematologic overall response rate;Percentage of hematologic very good partial response or better;Time to first hematologic response or best response;Progression-free survival;Overall survival;Safety analysis; | — |
Countries
China
Contacts
Public ContactChunrui Li
Outcome results
None listed